BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP HBSAG ASSAY

    MDR report key: 2892853 · Received January 2, 2013

    Report

    Report Number
    1219913-2012-00430
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOM
    PMA / PMN Number
    P030049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE VERIFIED THE PERFORMANCE OF THE LUMINOMETER DARK COUNTS, REAGENT AND SAMPLE PROBE CALIBRATIONS, SYSTEM DISPENSE AND ASPIRATION PROCESS, ACID AND BASE VOLUME DISPENSE AND REAGENT MANIFOLD. THE SAMPLE PROBE PLUNGER WAS CLEANED AND THE ACID AND BASE RESERVOIR AND TUBING WAS DECONTAMINATED. THE CAUSE FOR THE INITIALLY (B)(6) ADVIA CENTAUR XP HBSAG RESULT IS UNKNOWN. THE QUALITY CONTROL RESULTS THAT WERE RUN FOR BOTH REAGENT LOTS AT THE TIME OF THE INCIDENT WERE WITHIN ACCEPTABLE RANGE LIMITS. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE (IFU) UNDER THE LIMITATION SECTION STATES THE FOLLOWING: "FOR DIAGNOSTIC PURPOSES, THE ADVIA CENTAUR HBSAG TEST RESULTS SHOULD ALWAYS BE ASSESSED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL EXAMINATION, AND OTHER FINDINGS.

    Description of Event or Problem · 1

    A (B)(6) ADVIA CENTAUR XP HBSAG RESULT WAS OBSERVED BY THE CUSTOMER WHEN PERFORMING A NEW REAGENT LOT PATIENT CORRELATION COMPARISON. AN INITIAL (B)(6) RESULT FROM THE PREVIOUS REAGENT LOT (167) WAS REPORTED TO THE PHYSICIAN WAS CONSIDERED DISCORDANT WHEN COMPARED TO A (B)(6) RESULT OBTAINED WITH THE NEW REAGENT LOT (168). THE CUSTOMER PERFORMED REPEAT TESTING OF THE DISCORDANT SAMPLE ON THE PREVIOUS RUN REAGENT LOT AND THE NEW REAGENT LOT AND THE RESULTS WERE (B)(6). CONFIRMATORY TESTING WAS RUN ON THE PATIENT SAMPLE AND THE (B)(6) RESULTS WAS CONFIRMED FOR BOTH REAGENT LOTS. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT (B)(6) ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208 ADVIA CENTAUR XP HBSAG ASSAY HBS IMMUNOASSAY LOM SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 167

    Patients

    Seq Age Sex Outcome Treatment
    1